Department of Health
and Human Services (HHS)
and Human Services (HHS)
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Eye Institute (NEI)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
R21 Exploratory/Developmental Research Grant
None
The purpose of this Funding Opportunity Announcement (FOA) is to recruit Early Stage Investigators (ESI) to pursue research programs of interest to NIH Chemical Countermeasures Research Program (CCRP) under the NIH Countermeasures Against Chemical Threats (CounterACT) grant/cooperative agreement program.
ESI CounterACT R21 projects may be exploratory, applied, proof of principle, or high risk-high impact research to discover safe and effective therapeutics to mitigate toxicities resulting from exposures to highly toxic chemicals.
A distinct feature for this FOA is that no preliminary data are required, expected, or encouraged. However, if available, minimal preliminary data are allowed. All preliminary data should be clearly marked and limited to one-half page, which may include one figure. Applications including preliminary data more than one-half page or more than one figure will be considered noncompliant with the FOA instructions and will not go forward to review.
Projects supported by this FOA will have an extended level of support (3 years) and are expected to generate preliminary data that would facilitate the development of competitive applications for more extensive funding support from the NIH CounterACT programs or other related initiatives. Investigators that compete successfully for this R21 mechanism will not lose their ESI status.
June 27, 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| July 27, 2021 | Not Applicable | Not Applicable | October 2021 | January 2022 | March 2022 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).
Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
A. Background and Overview
The NIH Chemical Countermeasures Research Program (CCRP) was established in 2006 by the National Institute of Allergy and Infectious Diseases (NIAID) to lead the research and early development of novel or improved therapeutics to mitigate the acute and long-term health effects of chemicals that have been identified by the U.S. Department of Homeland Security (DHS) as high consequence public health threats. These public health threat agents are highly toxic chemicals that could cause mass casualties after either deliberate terrorism-related release or inadvertently in the event of an industrial accident or natural disaster. The chemical threat spectrum includes chemical warfare agents (CWAs), toxic industrial chemicals and materials (TICs/TIMs), and pharmaceutical-based agents (PBAs).The CCRP is a trans-NIH effort, involving partnerships with the NEI, NIAID, NIAMS, NICHD, NIEHS, NIDA, and NINDS to execute the overall NIH Strategic Plan and Research Agenda for Medical Countermeasures Against Chemical Threats under the NIAID oversight and coordination.
Under the CCRP, the NIH Countermeasures Against Chemical Threats (CounterACT) grant and cooperative agreement program supports a network of extramural grants (R21), cooperative agreements (U01), and Centers (U54) that conduct research and early development of medical countermeasures (MCMs) to reduce mortality and morbidity during and/or after high consequence public emergency events involving the release of chemical agents. The scope of CCRP-supported research includes basic, translational, and pre-clinical studies aimed at the discovery and/or identification of better MCMs. To learn more about the CCRP and the NIAID leadership role, see DOI:10.1002/ddr.21707.
This Funding Opportunity Announcement (FOA) is intended to recruit Early Stage Investigators (ESIs) to pursue research programs of interest to the CCRP.
This FOA employs an enhanced R21 Research Grant mechanism to provide up to $400,000 in direct costs over three years, allowing expanded time and resources to develop a research project and support ESIs. As this is a R21 mechanism, ESIs that successfully compete for the NIH CounterACT ESI award will not lose their ESI status and will remain an Early-stage Investigator. All applicants to this FOA must meet the NIH definition of an Early Stage Investigator (ESI). If submitting a multiple-PD/PI application, all PD/PIs must fit the NIH ESI definition. Additionally, to increase the diversity of the NIH research community, applications from ESI investigators that are underrepresented in the biomedical, behavioral or clinical research workforce are encouraged. Such individuals include women, those from underrepresented racial and ethnic groups, those with disabilities, and those from disadvantaged backgrounds.
This FOA encourages applications for exploratory and developmental research projects to identify potential mechanisms of chemical toxicity and discover molecular targets for the development of novel MCMs.
Pilot studies may include basic research to identify candidate therapeutic targets, the creation and validation of screening assays for therapy development, and development of proof-of-principle efficacy data for the candidate therapy compounds. It is expected that these R21 projects will generate preliminary data that would facilitate the development of competitive applications for more extensive support from the NIH CounterACT Cooperative Agreement programs or other related initiatives.
CounterACT R21 ESI Program Directors/Principal Investigators (PDs/PIs) will become members of the CCRP and will be expected to participate in annual meetings of the NIH CounterACT Network to share information and ideas.
Preliminary Data: A distinct feature for this FOA is that no preliminary data are required, expected, or encouraged. However, if available, some minimal preliminary data is allowed. Preliminary data are defined as material which the applicant has independently produced and not yet published in a peer-reviewed journal or preprint that has a Digital Object Identifier (DOI). Such evidence, if provided, should not represent work involving the aims of the ESI Researcher application. All preliminary data must be clearly marked and limited to one-half page, which may include one figure. Applications including preliminary data more than one-half page or more than one figure will be considered noncompliant with the FOA instructions and not go forward to review. Figures containing published data must include citations within the figure legend. Published data that is included in the research plan, biographical sketch or elsewhere in the application must be cited adjacent to each occurrence. Data that is published must be unambiguously identified as such within the application.
B. Chemical Threats Supported by this FOA
The civilian chemical threat spectrum includes chemical warfare agents, toxic industrial chemicals, pesticides, pharmaceutical-based agents, and other chemicals that are included on the current Department of Homeland Security (DHS) List of Chemicals of Concern, which is for U.S. Government official use only and cannot be included in this FOA.
However, to aid in the selection of the chemical threats(s), the following are more examples of over 200 chemicals threat agents. These examples are categorized in Toxidromes grouped by mechanism of action and the toxic effects of the agents.
Chemical Threat Toxidromes
Applicants are strongly urged to contact the Scientific/Research staff listed in this FOA to determine if their proposed threat agent(s) is of interest for this FOA. Applications that propose research on chemical threats that are not included on the List of Chemicals of Concern will be considered non-responsive and will not be reviewed or considered for funding.
C. Scientific Scope/Research Topics
This FOA will only support research that is clearly relevant to the development of new or improved MCMs that will enhance our medical response capabilities during a chemical emergency. The scope of research supported under this R21 program includes, but is not limited to:
The primary focus for applications focusing on translational research should be to identify potential therapeutic targets and/or MCM hits that may be effective when administered after a mass casualty chemical exposure has occurred. Model development, screening activity, and efficacy studies should be designed and well justified with these MCM requirements in mind.
The concept of use of the MCM must be considered and explained in the application as it is applicable in a mass casualty/emergency setting, including timing and route of administration.
Novel therapies that have no practical utility during a mass casualty scenario may not be considered for funding. Research on pretreatment/prophylaxis, while allowable under this R21 mechanism, must not comprise more than 25% of the proposed project. This line of research should be utilized only to demonstrate preliminary proof-of-principle feasibility to support the potential for further post-exposure therapy efficacy research.
Therapeutics to prevent long-term or delayed chronic effects after an acute exposure would also be considered and may be appropriate for administration after field evacuation and in-hospital, such as prehospital administration of the drug to address acute lethal effects, or in-hospital treatment for long-term effects in survivors of the acute exposure.
In all cases, the concept should be clearly appropriate for a mass casualty event involving an acute exposure, not chronic environmental exposures over a long period, e.g. occupational or residential exposures.
Due to the urgency in need, lengthy time, and expense in bringing a new compound to regulatory approval, applicants are encouraged to consider drugs that are already approved by the Food and Drug Administration (FDA) for other indications, i.e., drug repurposing. Some of these drugs have been shown to be effective in treating victims of chemical exposures, and in some cases, the length of time to regulatory approval for a new indication may be shorter than for a new chemical entity.
Important links to FDA Guidance and other regulatory information relevant to MCM research and development can be found in the Resources and Tools Box on the NIH CounterACT website.
D. Special Biosafety Concerns for Research Projects
Many of the chemical threat agents of interest are extremely hazardous to humans. All applications must include a letter from appropriate institutional biosafety officials indicating that studies are deemed safe for research personnel and the environment (See letters of support in Section IV). Special biosafety certifications may be required to conduct research with some chemical threat agents, e.g., chemical warfare agents. Therefore, applicants are encouraged to collaborate with laboratories and contract research facilities that are already certified to work with restricted chemical agents, when applicable. Applicants are strongly encouraged to contact the Scientific/Research Contacts listed in this FOA for further information on working with restricted chemical agents.
E. Applications Not Responsive to this FOA
The following applications will be considered non-responsive and will not be reviewed for this FOA:
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The budget for direct costs for the three-year project period may not exceed $400,000. No more than $200,000 in direct costs may be requested in any single year.
The total project period for an application submitted in response to this funding opportunity may not exceed 3 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
.Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) and meets the NIH definition of an Early Stage Investigator (ESI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide. All applicants to this FOA must meet the NIH definition of an Early Stage Investigator, if submitting a multiple-PD/PI application, all multiple-PD/PIs must fit the NIH ESI definition.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
Letter of Intent
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
NIH CounterACT Program Manager
Shardell Spriggs, PhD
Telephone: 301-443-8189
Email: shardell.spriggs@mail.nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
R&R or Modular Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
The proposed budget should include travel support for the PD/PI to attend the Annual NIH CounterACT Network Research Symposium for each of the proposed project years, in addition to other anticipated travel associated with the research. Post-doc, junior, and diverse investigators are encouraged to attend these meetings and budgets should be planned accordingly.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: NIH CounterACT ESI applications only allow minimal preliminary data. Consequently, determinations of merit and feasibility will rely instead on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge, understanding or practice. Applicants are encouraged to provide justification for the proposed work through literature citations, data from other publicly available sources, analytical and computational models, or when available, from a limited amount of investigator-generated data.
Preliminary Data: Preliminary data are defined as material which the applicant has independently produced and not yet published in a peer-reviewed journal or preprint that has a Digital Object Identifier (DOI). Preliminary data are not required for this FOA. However, such evidence, if provided, should not represent work involving the aims of the ESI application. All preliminary data must be clearly marked and limited to one-half page, which may include one figure.
Applications including preliminary data more than one-half page or more than one figure will be considered noncompliant with the FOA instructions and not go forward to review.
Figures containing published data must include citations within the figure legend. Published data that is included in the research plan, biographical sketch or elsewhere in the application must be cited adjacent to each occurrence. Data that is published must be unambiguously identified as such within the application.
The proposed research will likely involve considerable risk that the work may not be successful, so applicants should clearly explain the significance of the proposed work to allow the reviewers to determine whether the potential impact outweighs these risks.
Applicants should also explain how success in this project could lead to further development under more advanced drug discovery and development efforts in future follow-on applications.
Letters of Support: Many of the chemical threat agents of interest to this announcement are extremely hazardous to humans. All applicants must include a letter from appropriate institutional biosafety officials indicating that studies are deemed safe for research personnel and the environment. This must be addressed in the application, including a description of adequate protection and safeguards if required. Special biosafety certifications may be required to conduct research with some restricted chemical threat agents, e.g. chemical warfare nerve agents. Therefore, applicants must include a letter from appropriate Department of Defense (DoD) officials if utilizing such restricted agents. A formal letter of support (and estimated budget, if applicable) must also be provided for all proposed collaborative, consultative, and/or contract arrangements. This is especially needed for those contracted partnerships specifically for the utilization of restricted chemicals.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
The following modifications also apply:
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH and responsiveness by components of participating organizations. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
NIH CounterACT ESI R21 grant applications are required to have minimal or no preliminary data. Reviewers' determination of merit will rely on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge, understanding or practice. Appropriate justification for the proposed work can be provided through literature citations, data from publicly available sources, or analytical and computational models. The proposed research will likely involve considerable risk that the work may not be successful, so applicants should clearly explain the significance of the work to allow the reviewers to determine whether the potential impact justifies these risks.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Will results from the proposed study contribute to the basic scientific knowledge base related to chemical threats research, and/or the early development of a MCM that will reduce mortality and morbidity during and after emergency events involving the release of chemical threat agents?
If successful, are the results likely to generate the tools and/or proof-of-principle data necessary to facilitate the development of competitive research applications for further support?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Does the ESI(s) have appropriate experience and training? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
It is recognized that due to the nature of translational research, some studies may include existing methodologies such as standard tests and/or previously established models of chemical-induced injuries to explore a new scientific area. While these may not be considered especially innovative, they may nonetheless still be essential to advance the development of MCMs (and scientific knowledge) to achieve the goals of the CCRP.
Examples include but are not limited to preclinical safety evaluations, such as those striving to identify potential differences in vulnerabilities of specific subpopulation groups, or those seeking to determine the preclinical efficacy of FDA-approved/unapproved compounds.
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Are special biosafety precautions for working with highly toxic chemicals adequate? If working with restricted chemical agents, are all institutional approvals in place? Were the formal letters of collaboration for all proposed collaborative arrangements (and estimated budget) provided with the application adequate, especially those utilizing restricted chemical agents?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Shardell Spriggs, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-443-8189
Email: shardell.spriggs@mail.nih.gov
Dave Yeung, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 301-761-7237
E-mail: dy70v@nih.gov
Kiran Rv Vemuri
National Institute On Drug Abuse (NIDA)
Phone: 301-402-3396
E-mail:kiran.vemuri@nih.gov
Hung H Tseng
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-496-0810
E-mail: tsengh@mail.nih.gov
Srikanth Nadadur
National Institute Of Environmental Health Sciences (NIEHS)
Phone: 984-287-3296
E-mail: nadadurs@niehs.nih.gov
Houmam H Araj
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: ha50c@nih.gov
James Mack, Ph.D.
Center for Scientific Review
Telephone: 301-435-2037
Email: mackj2@mail.nih.gov
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov
Jason Lundgren
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-669-2973
E-mail: Jason.Lundgren@nih.gov
Sheila Simmons
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-594-9812
E-mail: simmonss@mail.nih.gov
Jenny L Greer
National Institute Of Environmental Health Sciences (NIEHS)
Phone: 984.287.3332
E-mail: jenny.greer@nih.gov
Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: kyr@nei.nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
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